Kratom Use Disorder Management Using Clonidine and/or Buprenorphine

Withdrawal Syndrome Clinical Trial

Official title:

Kratom Use Disorder Management Using Clonidine and/or Buprenorphine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05883358
• Other study ID #: SalemAnes2022 Kratom Addiction
• Status: Recruiting
• Start date: July 2, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: Salem Anaesthesia Pain Clinic
• Contact: Olu Bamgbade, MD,FRCPC
• Phone: 17786286600
• Email: salem.painclinic[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Kratom is used for stimulant, analgesic, anxiolytic, and sedative effects. There is inadequate knowledge about Kratom addiction. Kratom withdrawal may be treated like opioid withdrawal.

Prospective observational crossover study of consenting adults who are undergoing Kratom withdrawal management. On alternate weeks, each patient receives treatment using Buprenorphine 5cmg/hr patch; or Clonidine tablet 0.1mg 4hourly; or combined Clonidine tablet 0.1mg 4hourly + Buprenorphine 5cmg/hr patch. Each patient will undergo treatment for 12 weeks.

Patients will use Subjective Opiate Withdrawal Scale (SOWS) to collect data on daily basis. SOWS is a patient-administered tool that is used to record the severity and presence of opiate withdrawal. The physician will also use Clinical Opiate Withdrawal Scale (COWS) to collect data on weekly basis. COWS is a clinician-administered tool that is used to record the signs of opiate withdrawal. A change in the COWS and SOWS scores by 6-points is considered significant.

Description:

Kratom herb is used for stimulant, analgesic, anxiolytic, and sedative effects. There is inadequate knowledge about Kratom dependence and withdrawal therapy. Kratom withdrawal may be treated with similar therapy for opioid withdrawal.

This is a prospective observational crossover study of consenting adult patients who are undergoing Kratom withdrawal management. On alternate weeks, each patient receives rotational treatment using Buprenorphine 5cmg/hr patch; or Clonidine tablet 0.1mg 4hourly; or combined Clonidine tablet 0.1mg 4hourly + Buprenorphine 5cmg/hr patch. Each patient will undergo Kratom withdrawal treatment for 12 continuous weeks.

The patient will use the Subjective Opiate Withdrawal Scale (SOWS), a special validated scale, to collect data on daily basis. The SOWS is a patient-administered tool that is used to record the severity and presence of opiate withdrawal symptoms. In addition, the physician will use the Clinical Opiate Withdrawal Scale (COWS), a special validated scale, to collect data on weekly basis. The COWS is a clinician-administered tool that is used to record the symptoms and signs of opiate withdrawal or substance abuse disorder. A change in the COWS and SOWS scores by 6-points is considered significant.

Data analyzed with IBM® SPSS® Statistics 25 (IBM Corp, Armonk, NY); using Student's t-test, ANOVA, Pearson Chi-square test, and regression analysis. P-value <0.05 is considered significant.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 99 Years

Eligibility

Inclusion Criteria:

• adult patients

• Kratom dependence

• Kratom withdrawal syndrome

• Kratom withdrawal therapy

• good treatment compliance

• reliable Subjective Opiate Withdrawal Scale (SOWS) diary

• reliable Clinical Opiate Withdrawal Scale (COWS) diary

• informed consent for diary review

• consent for clinical record quality assurance review

Exclusion Criteria:

• poor treatment compliance

• cognitive disorder

• inability to provide consent

• major neuropsychiatric disorder

• unreliable diary

• cannabis use

• excessive alcohol intake

• previous adverse/allergic reactions to clonidine

• previous adverse/allergic reactions to buprenorphine

Related Conditions & MeSH terms

• Substance Withdrawal Syndrome
• Withdrawal Syndrome

Intervention

Drug:
• Clonidine, Buprenorphine
Each patient receives rotational treatment using Buprenorphine 5cmg/hr patch; or Clonidine tablet 0.1mg 4hourly; or combined Clonidine tablet 0.1mg 4hourly + Buprenorphine 5cmg/hr patch.

Locations

Country	Name	City	State
Canada	Salem Anaesthesia Pain Clinic	Surrey	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Salem Anaesthesia Pain Clinic

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Opiate Withdrawal Score	Clinical Opiate Withdrawal Score on a scale of 5 to 36; low scores indicate mild withdrawal, high scores indicate severe withdrawal	12 weeks